ALLO-329 / Allogene Therap - LARVOL DELTA

RESOLUTION: A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Allogene Therapeutics

New P1 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID (GlobeNewswire) - "The Phase 1 RESOLUTION basket trial in rheumatology launched in Q2 2025....The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data."

P1 data • Trial status • Immunology • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis

Allogene Therapeutics Reports First Quarter 2025 Financial Results and Business Update (GlobeNewswire) - "ALLO-329:...The Phase 1 RESOLUTION basket trial in rheumatology will begin in mid-2025. The trial will include patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis. The innovative design of the RESOLUTION trial will include two distinct lymphodepletion arms: one using a dose of cyclophosphamide alone and another that eliminates lymphodepletion entirely. The Company has shifted timing for its first update to this program to 1H 2026 to allow for both biomarker and clinical proof-of-concept data."

New P1 trial • Lupus Nephritis • Rheumatology • Systemic Lupus Erythematosus • Systemic Sclerosis

Allogene Granted Three U.S. FDA Fast Track Designations (FTD) for ALLO-329, a Next-Generation Dual-Targeted CD19/CD70 Allogeneic CAR T, for the Treatment of Lupus, Myositis and Scleroderma (GlobeNewswire) - "Allogene Therapeutics, Inc...announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three Fast Track Designations (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with: active refractory moderate-to-severe systemic lupus erythematous (SLE); active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immune mediated necrotizing myopathy and anti-synthetase syndrome; and active refractory diffuse systemic sclerosis (SSc)....Phase 1 RESOLUTION Trial Initiation Planned for Mid-2025 with Initial Proof-of-Concept by Year-End 2025."

Fast track • New P1 trial • Lupus • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID (GlobeNewswire) - "In January 2025, the FDA cleared the IND application to initiate clinical trials of ALLO-329 in patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis....The trial is scheduled to begin in mid-2025, aiming to provide proof-of-concept around year-end 2025."

New P1 trial • P1 data • Immunology • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis

Allogene Therapeutics Secures U.S. FDA IND Clearance for ALLO-329, Advancing its Next-Generation Allogeneic CAR T into Autoimmune Diseases (GlobeNewswire) - "Allogene Therapeutics...today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a rheumatology basket study of ALLO-329, an investigational allogeneic CAR T product...The Phase 1 RESOLUTION basket trial will evaluate the safety and preliminary efficacy of ALLO-329 in patients with systemic lupus erythematosus, including lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis....The RESOLUTION trial is scheduled to begin in mid-2025, aiming to provide critical insights into the potential of ALLO-329 to transform the treatment landscape for autoimmune diseases."

IND • New P1 trial • Immunology • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis

Preclinical Evaluation of ALLO-329: Allogeneic CD19 CAR T Cells Expressing an Anti-Rejection CD70 CAR for the Treatment of Autoimmune Diseases (ACR Convergence 2024) - "ALLO-329 can be successfully produced via ABR-001-mediated site-specific integration of a single bicistronic construct in the TRAC locus, successfully yielding high numbers of CAR+ cells that show specific cytotoxic activity, rejection avoidance, and the ability to eradicate B cells in mouse tissues. This novel off-the-shelf allogeneic CD70/CD19 CAR T cell product is a promising candidate for clinical evaluation."

CAR T-Cell Therapy • IO biomarker • Preclinical • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Lymphoma • Myositis • Non-Hodgkin’s Lymphoma • Oncology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • CD19 • CD70

Allogene Therapeutics Presents Preclinical Data for ALLO-329, an Allogeneic CD19/CD70 Dual CAR T for the Treatment of Autoimmune Disease at the American College of Rheumatology (ACR) Convergence (GlobeNewswire) - "Allogene Therapeutics....today announced preclinical data for ALLO-329, an investigational allogeneic CD19/CD70 dual CAR T cell therapy being evaluated as a treatment for autoimmune diseases....High CAR expression and cytotoxic activity: ALLO-329 produced through site-specific integration of a dual CAR construct into the TRAC locus demonstrated robust CAR expression and specific cytotoxic activity against both CD19+ B cells and CD70+ T cells in vitro and in vivo....B cell depletion and antibody reduction: ALLO-329 effectively eradicated B cells derived from healthy donors and patients with systemic lupus erythematosus (SLE) in vitro and in vivo, leading to a reduction in IgG and IgM production.'"

Preclinical • Immunology • Systemic Lupus Erythematosus

Allogene Therapeutics to Present Pre-Clinical Data Highlighting the Potential of ALLO-329, an Allogeneic CD19/CD70 Dual CAR T for the Treatment of Autoimmune Diseases, at the American College of Rheumatology (ACR) Convergence (GlobeNewswire) - "Allogene Therapeutics...today announced that it will present pre-clinical data for its next-generation investigational AlloCAR T candidate for autoimmune indications, ALLO-329, at the American College of Rheumatology's annual meeting, ACR Convergence 2024, being held from November 14-19 in Washington, D.C....The Company plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration in the first quarter of 2025 and expects to have proof-of-concept by year-end 2025."

Clinical data • IND • Preclinical • Immunology

Allogene Therapeutics Reports First Quarter 2024 Financial Results and Business Update (GlobeNewswire) - "ALLO-329 in Autoimmune Disease (AID): IND Submission Planned for Q1 2025 with Proof-of-Concept Data Expected by YE 2025."

Clinical data • IND • Immunology

Allogene Therapeutics Announces 2024 Platform Vision to Redefine the Future of CAR T Led by ALPHA3, the Industry’s First Pivotal Trial for Frontline Consolidation in Large B-Cell Lymphoma (GlobeNewswire) - "The Disruptor: ALLO-329 CD19 Dagger™ in Autoimmune Disease...Incorporation of the Dagger technology into an off-the-shelf CD19 product for use in AID is designed to reduce or eliminate the need for standard chemotherapy while targeting CD19+ B-cells and CD70+ activated T-cells, both of which play a role in AID. Initiation of this Phase 1 trial with ALLO-329 is expected in early 2025."

New P1 trial • Immunology